Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin; Glimepiride

Criteria

Inclusion Criteria:

1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).

2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).

3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).

4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).

5. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).